BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 CONSOLE FOR 4 PUMP

    MDR report key: 17256324 · Received July 5, 2023

    Report

    Report Number
    9611109-2023-00302
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 8, 2023
    Report Date
    September 25, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K210130
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN UNITED STATES. LIVANOVA CONTACTED THE BIOMED AT CUSTOMER SITE AND PROVIDED INFORMATION ON THE POSSIBLE CAUSE OF THE ERROR. LIVANOVA HAS RECOMMENDED TO REPLACE THE PARTS. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE INVOLVED PUMP IS INSTALLED SINCE 2019 AND ACCORDING TO THE REVIEW OF THE COMPLAINT DATABASE, NO FURTHER EVENT HAS BEEN REPORTED FOR THIS UNIT. NO SERVICE INTERVENTION HAS BEEN PERFORMED BY LN TECHNICIAN THAT PROVIDED PHONE SUPPORT TO THE BIOMED IN CHARGE. THE ERROR CODE 441 (A SAFETY FEATURE OF THE PUMP HAS FAILED; THE PUMP NO LONGER ALLOWS THE SYSTEM TO MONITOR IT PROPERLY.) ACCORDING TO SERVICE MANUAL, CAN BE CAUSED BY: -FAULT IN CIRCUIT BOARD HKR -FAULT IN CIRCUIT BOARD HMS -DEFECTIVE CONNECTIONS BETWEEN THE CIRCUIT BOARD MOTOR CONTROLLER (HMS 0409) AND THE CIRCUIT BOARD COMPUTER BOARD (HKR 0325) -DEFECTIVE CABLES -DEFECTIVE HALL SENSORS. NO OTHER SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY, LIVANOVA MAINTAINS AND DOCUMENTS PERIODIC CUSTOMER EVENTS MONITORING PROCESS IN ORDER TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND HAS RECEIVED A REPORT THAT A S5 HEART LUNG MACHINE DISPLAYED ERRROR MEANING FAULT IN MOTOR CONTROLLER (ERROR 441) DURING A PROCEDURE. THE ERROR IS NOW GONE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786933 S5 CONSOLE FOR 4 PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND GMBH 48-40-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown